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EC number: 249-535-3 | CAS number: 29253-36-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
No studies on primary irritation are available. The assessment of skin and eye irritation has been based on read-across to closely structure-related substances, such as methylnaphthalene and diisopropylnaphthalene (DIPN). There were no but slight initial effects on rabbit´s skin and eyes in three valid studies each.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, Lengerich, Germany
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.50 - 2.90 kg
- Housing: singly in steel cages with perforated plate floors above litter-filled dung troughs
- Diet: Ssniff K complete rabbit diet (Ssniff Versuchstier-Diäten GmbH, Soest, Germany), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk, size ca. 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: impermeable adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining test substance was removed by wiping with single-use paper towels.
- Time after start of exposure: 4 h
SCORING SYSTEM: according to Draize (similar to table "Grading of Skin Reactions" of OECD TG 404) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- In 2/3 animals, slight erythemas and edemas (score) were noted 1 h post-applicationion, which was still from 24 through 72 h in one animal. Scab formation was observed at the treatment site of all animals after 7 d.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a primary skin irritation test, 1-methylnaphthalene, a structure-analogous substance, was found to be slightly irritating according to the scoring system of Draize. According to EU regulations, no classification as to skin irritation is required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, basic data given (deviations: first observation 24 h after application, differing scoring system, observation period reduced, limited reporting)
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission, USA; Code of Federal Regulations, Title 16, Section 1500.42
- Principles of method if other than guideline:
- The method used is similar to the OECD test guideline 405 (Acute Eye Irritation/Corrosion) with some deviations (first observation 24 h after application, differing scoring system, observation period reduced, limited reporting)
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye of the animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize (max. score 110) (ETAD recommendation) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 24, 48, and 72 h (1, 2, and 3 days)
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects were observed in any of the test animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 24, 48, and 72 h (1, 2, and 3 days)
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no effects were observed in any of the test animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 24, 48, and 72 h (1, 2, and 3 days)
- Score:
- 1.22
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days (5 animals)
- Remarks on result:
- other: observation period only 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 24, 48, and 72 h (1, 2, and 3 days)
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days (2 animals)
- Remarks on result:
- other: observation period only 7 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 24 h
- Score:
- 6.67
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 48 h
- Score:
- 6
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- other: 72 h
- Score:
- 8.33
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: day 7
- Score:
- 3
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: observation period only 7 days
- Irritant / corrosive response data:
- For cornea and iris, no effects were observed. Conjunctivae and chemosis scores were moderate to low. In individual animals, the maximum mean (24 to 72 h) values were 1.67 (one value) or lower. At day 7, four animals still showed effects (conjunctivae 3 animal, grad 1 or 2; chemosis 2 animals, grade 1).
- Other effects:
- In two animals continuing eye secretion was observed up to day 7.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was not conducted following current test procedures. But readings were taken at the appropriate time points and scoring was performed according to Draize. Thus cornea, iris, conjunctivae and chemosis scores according to OECD TG 405 can be extracted from the reported values. Observation period was only 7 days. But the scores observed were moderate and had in general declined until day 7. Hence, it is estimated that the effects observed will be fully reversible within 21 days.
Reference
Eye irritation scores of individual rabbits (grading according to OECD TG 405; original scores are presented in the attached table under Attached background material)
|
Cornea |
Iris |
Conjunctivae |
Chemosis |
||||||||||||||||
Day after TS installation |
1 |
2 |
3 |
mean |
7 |
1 |
2 |
3 |
mean |
7 |
1 |
2 |
3 |
mean |
7 |
1 |
2 |
3 |
mean |
7 |
Rabbit 1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0.67 |
0 |
0 |
1 |
1 |
0.67 |
0 |
Rabbit 2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
1.33 |
0 |
2 |
2 |
1 |
1.67 |
1 |
Rabbit 3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
1.33 |
2 |
1 |
1 |
2 |
1.33 |
1 |
Rabbit 4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
1.33 |
0 |
1 |
1 |
2 |
1.33 |
0 |
Rabbit 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
0 |
1.33 |
1 |
2 |
1 |
1 |
1.33 |
0 |
Rabbit 6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
1.33 |
1 |
1 |
1 |
1 |
1.00 |
0 |
mean |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.33 |
1.00 |
1.33 |
1.22 |
0.67 |
1.17 |
1.17 |
1.33 |
1.22 |
0.33 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
acceptable for assessment, SAR (read-across) to a chemical structure closely related to that of the target substance.
Justification for selection of eye irritation endpoint:
acceptable for assessment, SAR (read-across) to a chemical structure closely related to that of the target substance.
Justification for classification or non-classification
The assessment of skin irritation has been based on read-across to closely structure-related substances, such as methylnaphthalene and diisopropylnaphthalene (DIPN). It is assumed that MIPN isomer mixture (MIPN) shows a similar irritation profile. Hence, no classification is required for the target compound.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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